Pharmacovigilance
We are seeing global progress in the implementation of IDMP. EMA has brought live elements of their SPOR (PMS, OMS, RMS) program and work with input from multiple regulators continues.
IDMP / FHIR
The transition to E2B (R3) for electronic submission of ICSRs continues. Vendors have rolled out R3-compliant versions of their PV databases. More and more jurisdictions make the new format mandatory, and almost every regulator adds local/regional fields with additional rules. So, E2B (R3) compliance continues to be a (slowly?) moving target.
E2B
Tools
Downloading information from EudraVigilance is a mandatory activity since 22-Nov-2017. Identifying and selecting what to download and eventually import in their own databases is not a simple task for many authorization holders. Tools are available to help manage these tasks efficiently. Let us help you leverage them.
Managing submissions is a major task in pharmacovigilance. Even without (or to support) a dedicated safety system, specialized tools are available which make the handling and maintenance of dozens or even hundreds of submissions a breeze.
Learning and Learning Management
Managing submissions is a major task in pharmacovigilance. Even without (or to support) a dedicated safety system, specialized tools are available which make the handling and maintenance of dozens or even hundreds of submissions a breeze.
